RecruitingNCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

Sponsor

Abbott Medical Devices

Enrollment

8,744 participants

Start Date

Jun 21, 2022

Study Type

OBSERVATIONAL

Conditions

Arrythmia Bradycardia Cardiac Pacemaker

Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Aveir VR Leadless Pacemaker System and a medical device called Single-Chamber Transvenous Pacemaker for people with arrythmia, bradycardia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAveir VR Leadless Pacemaker System

This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.

DEVICESingle-Chamber Transvenous Pacemaker

This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.